With the EU MDR (2017/745) replacing the current MDD (93/42/EEC) in the EU, many changes are on the horizon and will improve and modernize the current system to ensure the safety of devices. Some of those major changes are the requirements Notified Bodies must conform to once the MDR is in full effect.
With the changes the MDR is enforcing, Notified Bodies “are required to now demonstrate increased, more granular technical experience in their scope of designation, as well as improved quality management systems” (Brooks). They will be audited by Competent Authorities and EC representatives, and can expect more regular and consistent audits. The changing requirements have led to a decline in the number of active Notified Bodies. In October 2017, the number of Notified Bodies was reported to have dropped from over 83 active Notified Bodies to around 52 (Brooks).
One issue current Notified Bodies face is the ability to staff for the coming changes. Active Notified Bodies need to hire, train, and increase competency of the new regulations, affecting their current workloads. Notified Bodies need to manage current workload while actively hiring and training auditors to meet the new requirements, with training new auditors taking up to a year. This has had an impact on current active Notified Bodies, as the MDR comes with a greater emphasis on more regular and thorough reviews of data and documentation held by compliant device companies (Brooks; Maxwell).
At this time, 23 Notified Bodies, including BSI, DEKRA, and TUV, part of TEAM-NB (The European Association of Medical Notified Bodies), have announced timelines for applying to the new Notified Body designation under the MDR. It is not known if smaller companies will be able to meet the demands of the MDR.
Preparation for the implementation of the MDR is integral, as waiting until the last minute to submit to a Notified Body for review of documentation could result in being part of significant backlogs of documentation requiring review. Manufacturers need to plan accordingly, as the number of active Notified Bodies is shrinking, and workloads are increasing to prepare for the implementation.
Fang Consulting is equipped to help with your documentation needs when transitioning from MDD to MDR. We perform thorough gap analyses on current documentation to identify where changes need to be made, and we update current technical documentation to meet the new requirements. Preparation is key, and Fang Consulting can help your company transition early to the new requirements to avoid rushing to finalize documentation.